QbD Presentations on Parade: DynoChem's User Meeting

DynoChem has made available presentations from its user group this past May. Registration is required to access the content, but among the materials available are:

Roles of Mechanistic and Empirical Modeling/DOE in Achieving Quality by Design, by Paul Stonestreet of GSK

Practical Insight on New Model Development: Filtration and Centrifugation, by Rich Ballenger of Abbott

Process Modeling Based Approach Towards Quality by Design for an API Synthetic Step, by Shawn Brueggemeier, Emily Reiff, Olav Lyngberg, Lindsay Hobson, and Jose Tabora, BMS

Practical Aspects of Distillation Modeling in DynoChem, by Carolyn Cummings of Amgen

An Example from GSK's Design for Manufacture Initiative: Use of Dynochem in Conjunction with Lab and Pilot Scale Data to Advance Process Understanding, by Dharmesh Bhanushali of GSK

How Process Safety and Environmental Lab Can Guide Process Development, by Viviane Massonneau of Merck

Lean and Green: The Value of API Process Design, by David am Ende, Pfizer

--Paul Thomas

How Varian Complements Agilent for QbD

Agilent's purchase of Varian should give the company much more prominence in the QbD space. As Investor's Business Daily put it, "Varian's products are used to help design new therapeutic drugs, while Agilent's products help analyze the causes and cures for diseases."

Here are a couple white papers out from Agilent this year:

Using Design of Experiments for HPLC Method Development

Using Fiber Optics to Speed and Simplify Formulation and Method Development

--Paul Thomas

The QbD/Six Sigma Connection, Revisited

I had a good talk a few weeks back with Patheon CEO Wes Wheeler about initiatives he's undertaken to increase performance across all sites, and to use performance indicators to drive marketing for new business. (Article here.) I also e-communicated with Patheon executive VP and CTO Paul Garofolo about the company's Patheon Advantage Lean Six Sigma and its ongoing progress. You can read that Q&A here, but I thought Garofolo's take on the QbD/Six Sigma overlap helpful:

PhM: Where is Patheon in terms of adhering to FDA’s vision of Quality by Design, and what role does QbD play in the PA program?

P.G.: We’re making great progress. It’s all about culture change, on both fronts. The fundamentals of Lean Six Sigma support the fundamentals of QbD. Some tools, particularly Quality Function Deployment, Design for Six Sigma and Design of Experiments are particularly well-matched with QbD. We’re finding that the methods we’re developing and the culture change we’re building with PA support fully our move to QbD.

--Paul Thomas